The Thalidomide Of Genetic Engineering

By the end of the 1980s
some millions of people, mostly in North America, were
supplementing their diet with L-tryptophan, an essential
amino-acid present in proteins of any normal diet.
Amino-acids such as tryptophan are routinely produced in
micro-breweries using suitable microbial cultures. One
producer, Showa Denko K.K., artificially inserted genes into
a bacterial species to increase its production of
tryptophan.

Then in late 1989, some 5,000 - 10,000 in
North America fell ill with a highly unusual if not
completely novel illness, EMS (eosinophilia-myalgia
syndrome) caused by Showa Denko tryptophan. Within months,
dozens had been killed and thousands maimed. Today thousands
continue to suffer permanent nasty effects, and a trickle of
them continue to die early (at least 80 total by now). The
epidemic ceased when non-prescription tryptophan was
severely restricted.

We emphasize that if thalidomide had
happened to cause a type of birth defect that was already
common, e.g. cleft palate or severe mental retardation, we
would still not know about the harm, and pregnant women
would have kept on taking it for its undoubted benefits.
The fractional addition to figures which were already
relatively large would not have been statistically
significant. But as it turned out, the damage noticed was
of a kind that most doctors never see in a whole career -
drastic malformations of the arms & legs - so although the
numbers were not huge these cases were picked up.

Similarly, impurities in the GE tryptophan happened to cause
an illness (EMS) which was novel. The surge of numbers
therefore stood out and got noticed. If Showa Denko's
poison had caused the same numbers but of a common illness
instead, say asthma, we would still not know about it. Or
if it had caused delayed harm, such as cancer 20 - 30 years
later, or senile dementia in some whose mothers had taken it
early in pregnancy, there would have been no way to
attribute the harm to the cause.

This reminds us of the
need for extreme caution with GE foods. They must be
assumed guilty until lengthy tests have suggested they are,
if not innocent, at worst guilty of only minor dangers.
Such is nowhere near the case today as large companies rush
to market their GE foods.

It is very disappointing to
find a leading physician, Prof Sir John Scott, writing about
this disaster thus: "Rare cases of EMS were known before the
introduction of the genetically engineered bacterium, which
further supports the hypothesis that EMS is not due to the
genetic engineering event." An exact analogue of that
argument would run: "Rare cases of seal-limb were known
before the introduction of thalidomide, which further
supports the hypothesis that seal-limb is not due to
thalidomide." But even more important is the fact that the
trickle of about 100 early cases, years before the epidemic
of late 1989, were due to (early versions of) Showa Denko GE
microbial cultures. No other manufacturer's tryptophan
caused EMS.

The contrast is startling with the elaborate
procedure before registration of a new drug. It has taken a
decade to get legal approval for supplementing humans with
(a modified version of) the human hormone amylin, for
treating diabetics. Yet GE foods are urged for legal
distribution in great haste and with only extremely scanty
testing, and the main discussion so far has been whether
they should be labelled.

Labelling would not in itself be
wrong, but can of course not substitute for the careful
lengthy testing that would be needed before any GE food
should be approved for human consumption. Labelling of GE
food would imply acceptance by authorities, as does the
ingredient list of any labelled food.

The Showa Denko
disaster is crucial to understanding GE food. If a purified
single chemical - the natural amino-acid L-tryptophan,
better than 99% pure and definitely meeting the notorious
'substantial equivalence' test - can turn out when GEd to
kill dozens and cripple thousands, what will it take to
check properly a potato containing a synthetic 'exact' copy
of a gene for a toxin from the African clawed toad?

And
most urgently, the attempt to count as 'substantially
equivalent' purified sugars, oils etc. is shown by the Showa
Denko disaster to be a gamble. The assumption that soy oil
from GE soybeans is exactly equivalent to ordinary soy oil
requires the most careful scientific measurements to check
it. Merely assuming 'substantial equivalence' will not
do.

Those who search the internet on this topic will soon
discover the claim by apologists for GE that the problem was
only decreased purification of tryptophan. We disagree for
several reasons - mainly, the first 3 GE strains had been
causing EMS for years before this slackening of procedure in
Jan 1989 when also the superproducer strain went into
production and caused the epidemic. But this question
cannot be settled with finality unless Showa Denko release
the GE microbes for detailed examination.

Whether you
believe the impurities were due to incompetent purification
& monitoring, or to deviant metabolism in the GE-bugs, or
both, you had better believe that the fabled 'substantially
equivalent' assumption flopped in that epidemic of crippling
& lethal illness.

The most menacing forms of biotechnology
are genetically engineered foods and other uncontained GE
organisms, but some other forms of biotechnology entail
serious threats to public health which are under even less
control than chemical poisons - and that's saying
something.

If faulty filtering was indeed the problem, it
follows that the production of amino-acids and other 'Health
Food supplements' may be much more inherently hazardous than
has been believed. Perhaps the Health Food Industry should
be subject to controls on purity and safety comparable to
those applied to the pharmaceutical industry. Either way,
biotechnology - which includes GE but also includes other
processes such as purifying the mixture "lyprinol" from
green-lipped mussels - requires much-enhanced scrutiny.

Dr Mann, a biochemist, served for its
first dozen years on the Toxic Substances Board advising
successive New Zealand ministers of health on poisons. Dr
Straton is a psychiatrist who has taken a special interest
in therapeutic uses of tryptophan. Mr Crist is a publicist
who has interviewed researchers, victims, and lawyers
involved with EMS.

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